Pain Control With Caudal Epidural vs. Combined Caudal Epidural and Lumbar Sympathetic Block .
NCT ID: NCT07199816
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
64 participants
INTERVENTIONAL
2025-06-01
2026-08-01
Brief Summary
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Detailed Description
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* To assess and compare the improvement of motor activity and early ambulation using EuroQo lmeasure (EQ-5D) between the two groups.
* To evaluate and compare the overall patient satisfaction between the two groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group C
Group C (n=32): this group will receive fluoroscopy guided caudal epidural block.
Under fluoroscopic guidance and the patients in prone position, caudal epidural injection will be achieved. A pillow will be inserted under the pelvic bones for better exposure and accessibility of thesacral hiatus. Betadine will be used for sterilization of the sacrococcygeal area and palpation of the coccygeal tip. Upon localization of the sacral hiatus, a 22-gauge, 3.5-inch length spinal needle (Spinocan®, BRAUN, Melsungen, Germany) with the image intensifier will be used to inject 1 mL of contrast media (Omnipaque 300; GE Healthcare, Carrigtohill, Co. Cork, Ireland). After confirming the right needle position and excluding intravascular, intrathecal, and soft tissue infiltration, 10 cc of the treatment drug (8 ml of 0.5%lidocaine mixed with 2ml of 8 mg dexamethasone) will be injected.
Fluoroscopy-Guided Caudal Epidural Block
Under fluoroscopic guidance, the patient in the prone position will receive a caudal epidural injection through the sacral hiatus. A 22-gauge, 3.5-inch spinal needle (Spinocan®, BRAUN) is used to inject 1 mL of contrast media (Omnipaque 300) to confirm correct needle placement. Then, 10 mL of treatment solution (8 mL of 0.5% lidocaine and 2 mL of 8 mg dexamethasone) is administered.
Group LC
Group LC: Group (n=32): this group will receive combined fluoroscopy guided caudal epidural block and lumbar sympathetic ganglion block.
Under fluoroscopic guidance, LSGB will be performed. The block level and side will be determined. Patients will be kept in the prone position while C-arm (GE OEC 9900 C- of the anteroposterior, oblique, and lateral view are examined to verify the correct entrance sit. The skin will be prepared in an aseptic manner. Approach the anterolateral border of the inferior sec of the L2 vertebral body or the upper portion of the L3 vertebral body of the affected side where the pain exists, using a 21-gauge Chiba needle.
Following the confirmation of the needle location via fluoroscopic imaging, an aspiration test will be performed in order to rule out the presence of blood, following by injection of a contrast medium. Following that, 2 mL of 8mg dexamethasone will be diluted with 8 mL of 1% lidocaine and injected unilaterally at one level.
Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block
Patients will receive both a caudal epidural block and a lumbar sympathetic ganglion block (LSGB) under fluoroscopic guidance. The LSGB is performed at the L2 or L3 vertebral body on the affected side using a 21-gauge Chiba needle. After confirming needle position with contrast imaging, 10 mL of solution (2 mL of 8 mg dexamethasone + 8 mL of 1% lidocaine) is injected. A caudal block is then performed as described above.
Interventions
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Fluoroscopy-Guided Caudal Epidural Block
Under fluoroscopic guidance, the patient in the prone position will receive a caudal epidural injection through the sacral hiatus. A 22-gauge, 3.5-inch spinal needle (Spinocan®, BRAUN) is used to inject 1 mL of contrast media (Omnipaque 300) to confirm correct needle placement. Then, 10 mL of treatment solution (8 mL of 0.5% lidocaine and 2 mL of 8 mg dexamethasone) is administered.
Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block
Patients will receive both a caudal epidural block and a lumbar sympathetic ganglion block (LSGB) under fluoroscopic guidance. The LSGB is performed at the L2 or L3 vertebral body on the affected side using a 21-gauge Chiba needle. After confirming needle position with contrast imaging, 10 mL of solution (2 mL of 8 mg dexamethasone + 8 mL of 1% lidocaine) is injected. A caudal block is then performed as described above.
Eligibility Criteria
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Inclusion Criteria
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I to III.
* Undergoing lumbar spine surgery level L4-5/ L5-S1 for the second time.
* Duration of chronic low back pain \> 3months.
Exclusion Criteria
* Bleeding disorder.
* patient refusal for the procedure.
* Pregnancy.
* Neoplastic diseases, allergies to contrast.
* Liver failure or kidney failure .
40 Years
70 Years
ALL
No
Sponsors
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Cairo University
OTHER
Hebatullah Mohammed Abdelmageed
OTHER
Responsible Party
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Hebatullah Mohammed Abdelmageed
Hebatullah Mohammed Abdelmageed, Principle Investigator
Locations
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Kasr Al-Ainy Medical School, Cairo University
Cairo, , Egypt
Countries
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Related Links
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Related Info
Other Identifiers
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N- 26- 2024/ MD
Identifier Type: -
Identifier Source: org_study_id